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General Assembly Substitute Bill No. 5396
February Session, 2022
AN ACT INCREASING ACCESS TO MENTAL HEALTH MEDICATION.
Be it enacted by the Senate and House of Representatives in General
Assembly convened:
Section 1. (Effective July 1, 2022) (a) As used in this section and section 1
2 of this act: 2
(1) "MDMA" means the synthetic psychoactive drug, 3,4-3
methylenedioxymethamphetamine, commonly known as ecstasy or 4
molly, that acts as a serotonin receptor agonist and reuptake inhibitor of 5
serotonin and dopamine. 6
(2) "Psilocybin" means a serotonin receptor agonist that occurs 7
naturally in some mushroom species. 8
(3) "Qualified patient" means a resident of the state who is (A) a 9
veteran, (B) a retired first responder, (C) a direct care health care worker, 10
or (D) from a historically underserved community, and who has a 11
serious or life-threatening mental or behavioral health disorder and 12
without access to effective mental or behavioral health medication. 13
(4) "Qualified applicant" means a provider of mental or behavioral 14
health services that has received approval from the federal Food and 15
Drug Administration as an approved treatment site with an expanded 16
access protocol that allows the provider access to an investigational 17 Substitute Bill No. 5396
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drug for treatment use, including emergency use, pursuant to 21 CFR 18
312, as amended from time to time. 19
(5) "Approved treatment site" means the location where a qualified 20
applicant that has been selected under subsection (e) of this section as a 21
provider of MDMA-assisted or psilocybin-assisted therapy under the 22
pilot program established pursuant to subsection (b) of this section will 23
provide such therapy. 24
(b) There is established, within the Department of Mental Health and 25
Addiction Services, a psychedelic-assisted therapy pilot program to 26
provide qualified patients with the funding necessary to receive 27
MDMA-assisted or psilocybin-assisted therapy as part of an expanded 28
access program approved by the federal Food and Drug Administration 29
pursuant to 21 CFR 312, as amended from time to time. The department 30
shall cease to operate the pilot program when MDMA and psilocybin 31
have been approved to have a medical use by the Drug Enforcement 32
Administration, or any successor agency. 33
(c) There is established a Qualified Patients for Approved Treatment 34
Sites Fund, "PAT Fund". The fund shall contain any moneys required by 35
law to be deposited in the fund and may contain any other funds as 36
provided in subsection (d) of this section. The Department of Mental 37
Health and Addiction Services shall administer and use the fund for 38
grants to qualified applicants to provide MDMA-assisted or psilocybin-39
assisted therapy to qualified patients under the pilot program 40
established pursuant to subsection (b) of this section. 41
(d) For the fiscal year ending on June 30, 2023, and for each fiscal year 42
thereafter, block grant funds allocated to the department pursuant to 43
section 4-28b of the general statutes may be deposited in said fund, and 44
the department may accept contributions from any source, public or 45
private, for deposit in said fund. 46
(e) On or before November 29, 2022, a qualified applicant may apply 47
to the Department of Mental Health and Addiction Services for selection 48 Substitute Bill No. 5396
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as an approved treatment site. The department shall: 49
(1) Develop an application form for qualified applicants seeking 50
selection as an approved treatment site and, not later than October 31, 51
2022, post such application on the department's Internet web site; 52
(2) Select up to three qualified applicants as approved treatment sites 53
not later than December 28, 2022; 54
(3) Distribute one million five hundred thousand dollars from the 55
PAT Fund equally amongst the approved treatment sites; and 56
(4) Distribute an additional one million five hundred thousand 57
dollars from the PAT Fund equally amongst the approved treatment 58
sites that, prior to March 31, 2023, provided proof of receipt of a one 59
million five hundred thousand dollar matching grant from a private 60
foundation to treat qualified patients. If no approved treatment site 61
provides proof of receipt of such matching grant on or before March 31, 62
2023, the department shall distribute an additional one million five 63
hundred thousand dollars from the PAT Fund equally amongst the 64
approved treatment sites not later than March 31, 2024. 65
(f) Approved treatment sites shall collect and submit data to the 66
Department of Mental Health and Addiction Services, including, but 67
not limited to, its protocols for the provision of MDMA-assisted and 68
psilocybin-assisted treatment, training on the facilitation of such 69
treatment, implementation of facility standards, strategies for patient 70
protection and mitigation of drug diversion. Approved treatment sites 71
shall follow all applicable patient privacy laws in the collection and 72
submission of data to the department. As used in this subsection, "drug 73
diversion" means the transfer of a legally prescribed drug from the 74
individual for whom it was prescribed to another individual for any 75
illicit use. 76
Sec. 2. (Effective July 1, 2022) (a) There is established the Connecticut 77
Psychedelic Treatment Advisory Board, which shall be part of the 78
Department of Mental Health and Addiction Services. 79 Substitute Bill No. 5396
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(b) The board shall consist of the following members: (1) Two 80
appointed by the speaker of the House of Representatives; (2) two 81
appointed by the president pro tempore of the Senate; (3) one appointed 82
by the minority leader of the House of Representatives; (4) one 83
appointed by the minority leader of the Senate; (5) two appointed by the 84
Office of the Governor; (6) one appointed by the Commissioner of 85
Mental Health and Addiction Services; (7) one appointed by the 86
Commissioner of Public Health; and (8) one appointed by the 87
Commissioner of Consumer Protection. The board shall include 88
members with experience or expertise in psychedelic research, 89
psychedelic-assisted therapy, public health, access to mental and 90
behavioral health care in underserved communities, veteran mental and 91
behavioral health care, harm reduction and sacramental use of 92
psychedelic substances. 93
(c) Notwithstanding the provisions of subsection (a) of section 4-9a of 94
the general statutes, the speaker of the House of Representatives and the 95
president pro tempore of the Senate shall select the chairpersons of the 96
board from among the members of the board. The chairpersons shall 97
oversee the establishment of and make recommendations regarding the 98
voting procedures of the board. 99
(d) The administrative staff of the joint standing committee of the 100
General Assembly having cognizance of matters relating to consumer 101
protection shall serve as administrative staff of the board, with 102
assistance as needed provided by employees of the Offices of Legislative 103
Research and Fiscal Analysis. 104
(e) The board shall advise the Department of Mental Health and 105
Addiction Services on the design and development of the regulations 106
and infrastructure necessary to safely allow for therapeutic access to 107
psychedelic-assisted therapy upon the legalization of MDMA, 108
psilocybin and any other psychedelic compounds. In advising the 109
department under this subsection, the board shall be responsible for: (1) 110
Reviewing and considering the data from the psychedelic-assisted 111
therapy pilot program established under section 1 of this act to inform 112 Substitute Bill No. 5396
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the development of such regulations; (2) advising the department on the 113
necessary education, training, licensing and credentialing of therapists 114
and facilitators, patient safety, harm reduction, the establishment of 115
equity measures in both clinical and therapeutic settings, cost and 116
insurance reimbursement considerations and standards of treatment 117
facilities; (3) advising the department on the use of group therapy and 118
other therapy options to reduce cost and maximize public health 119
benefits from psychedelic treatments; (4) monitoring updated federal 120
regulations and guidelines for referral and consideration by the state 121
agencies of cognizance for implementation of such regulations and 122
guidelines; (5) developing a long-term strategic plan to improve mental 123
health care through the use of psychedelic treatment; (6) recommending 124
equity measures for clinical subject recruitment and facilitator training 125
recruitment; and (7) assisting with the development of public awareness 126
and education campaigns. 127
(f) The board may establish committees and subcommittees 128
necessary for the operation of the board. 129
Sec. 3. Section 21a-243 of the general statutes is repealed and the 130
following is substituted in lieu thereof (Effective July 1, 2022): 131
(a) The Commissioner of Consumer Protection shall adopt 132
regulations for the efficient enforcement and operation of sections 21a-133
244 to 21a-282, inclusive. 134
(b) The Commissioner of Consumer Protection may, so far as may be 135
consistent with sections 21a-244 to 21a-282, inclusive, adopt the 136
regulations existing under the federal Controlled Substances Act and 137
pertinent regulations existing under the federal food and drug laws and 138
conform regulations adopted hereunder with those existing under the 139
federal Controlled Substances Act and federal food and drug laws. 140
(c) The Commissioner of Consumer Protection, acting upon the 141
advice of the Commission of Pharmacy, may by regulation designate, 142
after investigation, as a controlled substance, a substance or chemical 143 Substitute Bill No. 5396
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composition containing any quantity of a substance which has been 144
found to have a stimulant, depressant or hallucinogenic effect upon the 145
higher functions of the central nervous system and having a tendency 146
to promote abuse or physiological or psychological dependence or both. 147
Such substances are classifiable as amphetamine-type, barbiturate-type, 148
cannabis-type, cocaine-type, hallucinogenic, morphine-type and other 149
stimulant and depressant substances, and specifically exclude alcohol, 150
caffeine and nicotine. Substances which are designated as controlled 151
substances shall be classified in schedules I to V by regulations adopted 152
pursuant to subsection (a) of this section. 153
(d) The Commissioner of Consumer Protection may by regulation 154
change the schedule in which a substance classified as a controlled 155
substance in schedules I to V of the controlled substance scheduling 156
regulations is placed. On or before December 15, 1986, and annually 157
thereafter, the commissioner shall submit a list of all such schedule 158
changes to the chairmen and ranking members of the joint standing 159
committee of the General Assembly having cognizance of matters 160
relating to public health. 161
(e) Notwithstanding the provisions of subsections (a) to (d), inclusive, 162
of this section, not later than January 1, 2013, the Commissioner of 163
Consumer Protection shall submit amendments to sections 21a-243-7 164
and 21a-243-8 of the regulations of Connecticut state agencies to the 165
standing legislative regulation review committee to reclassify marijuana 166
as a controlled substance in schedule II under the Connecticut 167
controlled substance scheduling regulations, except that for any 168
marijuana product that has been approved by the federal Food and 169
Drug Administration or successor agency to have a medical use and that 170
is reclassified in any schedule of controlled substances or unscheduled 171
by the federal Drug Enforcement Administration or successor agency, 172
the commissioner shall adopt the schedule designated by the Drug 173
Enforcement Administration or successor agency. 174
(f) Notwithstanding the provisions of subsections (a) to (d), inclusive, 175
of this section, the Commissioner of Consumer Protection shall adopt 176 Substitute Bill No. 5396
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the schedule designated by the Drug Enforcement Administration or 177
successor agency for MDMA, as defined in section 1 of this act, and 178
psilocybin, as defined in said section, if MDMA and psilocybin have 179
been approved by said administration, or successor agency, to have a 180
medical use and are reclassified in any schedule of controlled substances 181
or unscheduled by said administration or successor agency. 182
[(f)] (g) A new or amended regulation under this chapter shall be 183
adopted in accordance with the provisions of chapter 54. 184
[(g)] (h) In the event of any inconsistency between the contents of 185
schedules I, II, III, IV and V of the controlled substance scheduling 186
regulations and schedules I, II, III, IV and V of the federal Controlled 187
Substances Act, as amended, the provisions of the federal act shall 188
prevail, except (1) when the provisions of the Connecticut controlled 189
substance scheduling regulations place a controlled substance in a 190
schedule with a higher numerical designation, schedule I being the 191
highest designation, or (2) as provided in subsection (e) of this section. 192
[(h)] (i) When a drug that is not a controlled substance in schedule I, 193
II, III, IV or V, as designated in the Connecticut controlled substance 194
scheduling regulations, is designated to be a controlled substance under 195
the federal Controlled Substances Act, such drug shall be considered to 196
be controlled at the state level in the same numerical schedule from the 197
effective date of the federal classification. Nothing in this section shall 198
prevent the Commissioner of Consumer Protection from designating a 199
controlled substance differently in the Connecticut controlled substance 200
scheduling regulations than such controlled substance is designated in 201
the federal Controlled Substances Act, as amended from time to time. 202
[(i)] (j) The Commissioner of Consumer Protection shall, by 203
regulation adopted pursuant to this section, designate the following 204
substances, by whatever official, common, usual, chemical or trade 205
name designation, as controlled substances and classify each such 206
substance in the appropriate schedule: 207 Substitute Bill No. 5396
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(1) 1-pentyl-3-(1-naphthoyl)indole (JWH-018); 208
(2) 1-butyl-3-(1-naphthoyl)indole (JWH-073); 209
(3) 1-[2-(4-morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-200); 210
(4) 5-(1,1-dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol 211
(CP-47,497); 212
(5) 5-(1,1-dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol 213
(cannabicyclohexanol; CP-47,497 C8 homologue); 214
(6) Salvia divinorum; and 215
(7) Salvinorum A. 216
[(j)] (k) Notwithstanding the provisions of subsection (c) of this 217
section, the Commissioner of Consumer Protection shall designate the 218
following substances, by whatever official, common, usual, chemical or 219
trade name designation, as controlled substances in schedule I of the 220
controlled substances scheduling regulations: 221
(1) Mephedrone (4-methylmethcathinone); and 222
(2) MDPV (3,4-methyenedioxypyrovalerone). 223
Sec. 4. (NEW) (Effective July 1, 2022) The Department of Consumer 224
Protection shall consider for adoption any nonbinding federal 225
guidelines from the federal Department of Health and Human Services 226
regarding the practice of psychedelic-assisted therapy. The Connecticut 227
Psychedelic Treatment Advisory Board established under section 2 of 228
this act and members of the public may submit written comments to the 229
department during a notice and comment period established by the 230
department regarding adoption of and any suggested changes to such 231
guidelines that may better meet the needs of state residents. The 232
department shall post the procedures and deadline for submission of 233
written comments during such notice and comment period on its 234
Internet web site. 235 Substitute Bill No. 5396
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Sec. 5. Subdivision (29) of section 21a-240 of the 2022 supplement to 236
the general statutes is repealed and the following is substituted in lieu 237
thereof (Effective July 1, 2022): 238
(29) "Marijuana" means all parts of any plant, or species of the genus 239
cannabis or any infra specific taxon thereof, whether growing or not; the 240
seeds thereof; the resin extracted from any part of the plant; every 241
compound, manufacture, salt, derivative, mixture, or preparation of 242
such plant, its seeds or resin, any product made using hemp, as defined 243
in section 22-61l, which exceeds three-tenths per cent total THC 244
concentration on a dry-weight basis; manufactured cannabinoids, 245
synthetic cannabinoids, except as provided in subparagraph (E) of this 246
subdivision; or cannabinon, cannabinol or cannabidiol and chemical 247
compounds which are similar to cannabinon, cannabinol or cannabidiol 248
in chemical structure or which are similar thereto in physiological effect, 249
which are controlled substances under this chapter, except cannabidiol 250
derived from hemp, as defined in section 22-61l, with a total THC 251
concentration of not more than three-tenths per cent on a dry-weight 252
basis. "Marijuana" does not include: (A) The mature stalks of such plant, 253
fiber produced from such stalks, oil or cake made from the seeds of such 254
plant, any other compound, manufacture, salt, derivative, mixture or 255
preparation of such mature stalks, except the resin extracted from such 256
mature stalks or fiber, oil or cake; (B) the sterilized seed of such plant 257
which is incapable of germination; (C) hemp, as defined in section 22-258
61l, with a total THC concentration of not more than three-tenths per 259
cent on a dry-weight basis; (D) any substance approved by the federal 260
Food and Drug Administration or successor agency as a drug and 261
reclassified in any schedule of controlled substances or unscheduled by 262
the federal Drug Enforcement Administration or successor agency 263
which is included in the same schedule designated by the federal Drug 264
Enforcement Administration or successor agency; or (E) synthetic 265
cannabinoids which are controlled substances that are designated by the 266
Commissioner of Consumer Protection, by whatever official, common, 267
usual, chemical or trade name designation, as controlled substances and 268
are classified in the appropriate schedule in accordance with 269 Substitute Bill No. 5396
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subsections [(i)] (j) and [(j)] (k) of section 21a-243, as amended by this 270
act; 271
Sec. 6. (Effective July 1, 2022) The sum of three million dollars is 272
appropriated to the Department of Mental Health and Addiction 273
Services from the General Fund, for the fiscal year ending June 30, 2023, 274
for deposit in the Qualified Patients for Approved Treatment Sites Fund 275
established under section 1 of this act. 276
This act shall take effect as follows and shall amend the following
sections:
Section July 1, 2022 New section
Sec. 2 July 1, 2022 New section
Sec. 3 July 1, 2022 21a-243
Sec. 4 July 1, 2022 New section
Sec. 5 July 1, 2022 21a-240(29)
Sec. 6 July 1, 2022 New section
Statement of Legislative Commissioners:
In Section 2(c), the phrase "Notwithstanding the provisions of
subsection (a) of section 4-9a of the general statutes, the" was added for
consistency with the controlling provision of the general statutes.
PH Joint Favorable Subst. -LCO